18 results · 20ms · Sources: EU EUDAMED, US FDA

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NEURO PULSE II,III

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Relievant Medsystems RF Generator

FDA 510(k)
FDA Class 2 ·Neurology

BD TRITEST CD3/CD4/CD45, MODEL 340383

FDA 510(k)
FDA Class 2 ·Hematology

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·February 1, 2013

RENAL - DISPOSABLE

FDA Adverse Event
Injury ·Product code KDJ·January 26, 2011

3.5MM X 16MM PRIMARY OPEN POLY SREW

FDA Adverse Event
Injury ·ZIMMER SPINE, INC.·Product code NKB·July 8, 2014

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

AIA-900

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·February 24, 2016

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

TOSOH AIA-900

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·December 13, 2016

BD TRUCOUNT TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

A1A-600II

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·October 28, 2016

TOSOH AIA-1800

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·November 11, 2016

AIA-360

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code KHO·March 3, 2016

BD TRUCOUNT¿ TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026